Intraocular lens inserters

ABSTRACT

An intraocular lens inserter can include an energy storage portion, an actuator portion, and a lens support portion. The energy storage portion can include a compressible energy storage device, such as a compressible fluid, springs, and other devices. The inserter can include an actuator portion operating with a substantially incompressible fluid, such as liquids or other noncompressible fluids. The actuator can be configured to provide an operator with control over the release of energy from the energy storage portion so as to move a plunger for the discharge of a lens from an intraocular lens cartridge.

RELATED APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

The present application is a continuation of International ApplicationNo. PCT/US2013/044183 filed Jun. 4, 2013, titled INTRAOCULAR LENSINSERTER and published as WO 2013/0184727, which claims priority to U.S.Provisional Patent Application No. 61/655,255 filed Jun. 4, 2012, theentire contents of both of which are hereby incorporated by reference.

TECHNICAL FIELD

The inventions disclosed herein generally relate to devices and methodsfor inserting intraocular lens into an eye of an animal.

BACKGROUND

A cataract is a clouding that develops in the crystalline lens of theeye or in its envelope (lens capsule), varying in degree from slight tocomplete opacity and obstructing the passage of light. Early in thedevelopment of age-related cataract, the power of the lens may beincreased, causing near-sightedness (myopia), and the gradual yellowingand opacification of the lens may reduce the perception of blue colors.Cataracts typically progress slowly to cause vision loss, and arepotentially blinding if untreated. The condition usually affects botheyes, but almost always one eye is affected earlier than the other. Thefollowing is a list of different types of cataracts:

Senile cataract—Characterized by an initial opacity in the lens,subsequent swelling of the lens, and final shrinkage with complete lossof transparency occurring in the elderly.

Morgagnian cataract—Liquefied cataract cortex forming a milky whitefluid, which can cause severe inflammation if the lens capsule rupturesand leaks, occurring as a progression of the cataract. Untreated, theadvanced cataract can cause phacomorphic glaucoma. Very advancedcataracts with weak zonules are liable to dislocation anteriorly orposteriorly.

Cataract resulting from trauma—A cataract resulting from trauma to theeye in an otherwise healthy individual. Blunt trauma or penetratingtrauma resulting from accidental injury to the eye can result incrystalline lens opacification. Retinal surgery involving a para planavitrectomy will result in a post-operative cataract in six to ninemonths after the surgery. Infrequently, an adverse event can occur whereby the otherwise healthy crystalline lens is touched by a surgicalinstrument during Retinal surgery. The crystalline lens clouds and acataract forms within minutes of the contact.

Congenital cataract—A cataract developed in a child before or just afterbirth.

In the United States, age-related lenticular changes have been reportedin 42% of those between the ages of 52 and 64, 60% of those between theages 65 and 74, and 91% of those between the ages of 75 and 85.

Age-related cataract is responsible for 48% of world blindness, whichrepresents about 18 million people, according to the World HealthOrganization. Continued population growth with the shift of the averageage will result in increased numbers of patients with cataracts. Theincrease in ultraviolet radiation resulting from depletion of the ozonelayer is expected to further increase the incidence of cataracts.

In many countries, surgical services are inadequate, and cataractsremain the leading cause of blindness. Cataracts are a large cause oflow vision in both developed and developing countries. Even wheresurgical services are available, low vision associated with cataractscan remain prevalent, as a result of long waits for operations andbarriers to surgical uptake, such as cost, lack of information andpatient transportation problems.

Several factors can promote the formation of cataracts, includinglong-term exposure to ultraviolet light, exposure to ionizing radiation,secondary effects of diseases such as diabetes, hypertension andadvanced age, or trauma (possibly much earlier); they are usually aresult of denaturation of lens protein. Genetic factors are often acause of congenital cataracts, and positive family history may also playa role in predisposing someone to cataracts at an earlier age, aphenomenon of “anticipation” in presenile cataracts. Cataracts may alsobe produced by eye injury or physical trauma.

A study among Icelandair pilots showed commercial airline pilots arethree times more likely to develop cataracts than people with nonflyingjobs. This is thought to be caused by excessive exposure at highaltitudes to radiation coming from outer space, which becomes attenuatedby atmospheric absorption at ground level. Supporting this theory is thereport that 33 of the 36 Apollo astronauts involved in the nine Apollomissions to leave Earth orbit have developed early stage cataracts thathave been shown to be caused by exposure to cosmic rays during theirtrips. At least 39 former astronauts have developed cataracts, of whom36 were involved in high-radiation missions such as the Apollo missions.

Cataracts are also unusually common in persons exposed to infraredradiation, such as glassblowers, who suffer from exfoliation syndrome.Exposure to microwave radiation can cause cataracts. Atopic or allergicconditions are also known to quicken the progression of cataracts,especially in children. Cataracts can also be caused by iodinedeficiency. Cataracts may be partial or complete, stationary orprogressive, or hard or soft. Some drugs can induce cataractdevelopment, such as corticosteroids and the antipsychotic drugquetiapine (sold as Seroquel, Ketipinor, or Quepin).

The operation to remove cataracts can be performed at any stage of theirdevelopment. There is no longer a reason to wait until a cataract is“ripe” before removing it. However, since all surgery involve some levelof risk, it is usually worth waiting until there is some change invision before removing the cataract.

The most effective and common treatment is to make an incision(capsulotomy) into the capsule of the cloudy lens to surgically removeit. Two types of eye surgery can be used to remove cataracts:extra-capsular cataract extraction (ECCE) and intra-capsular cataractextraction (ICCE). ECCE surgery consists of removing the lens, butleaving the majority of the lens capsule intact. High frequency soundwaves (phacoemulsification) are sometimes used to break up the lensbefore extraction. ICCE surgery involves removing the lens and lenscapsule, but it is rarely performed in modern practice. In eitherextra-capsular surgery or intra-capsular surgery, the cataractous lensis removed and replaced with an intraocular plastic lens (an intraocularlens implant) which stays in the eye permanently. The intraocular lensis placed into a cartridge and inserted through the small surgicalincision. The inserter folds the intraocular lens and pushed it througha small needle. The end of the needle is positioned within the capsularbag. When the folded intraocular lens exits the end of the needle, itslowly unfolds as the surgeon manipulated the lens into its finalposition. Cataract operations are usually performed using a localanesthetic, and the patient is allowed to go home the same day. Untilthe early twenty-first century intraocular lenses were always monofocal;since then improvements in intraocular technology allow implanting amultifocal lens to create a visual environment in which patients areless dependent on glasses. Such multifocal lenses are mechanicallyflexible and can be controlled using the eye muscles used to control thenatural lens.

Complications are possible after cataract surgery, includingendophthalmitis, posterior capsular opacification and retinaldetachment.

Laser surgery involves cutting away a small circle-shaped area of thelens capsule, enough to allow light to pass directly through the eye tothe retina. There are, as always, some risks, but serious side effectsare very rare. As of 2012 research into the use of extremely-short-pulse(femtosecond) lasers for cataract surgery was being carried out. Highfrequency ultrasound is currently the most common means to extract thecataract lens.

Cataract surgeries are conducted in an operating room under sterileconditions to prevent the risk of infection, particularlyendophthalmitis; a rapid devastating infection that can cause blindnessin a few days. The patient's eye is cleaned with an antiseptic, and thenisolated with a sterile drape that fully covers the patient with onlythe eye exposed. A sterile field is established around the patient suchthat any personnel or instrumentation must be suitably scrubbed, drapedor sterilized following standard aseptic procedures.

With reference to FIGS. 1 and 2, such a prior art type of cataractsurgery includes using a surgical microscope to view the interior of theeye through a patient's cornea and iris. The surgeon typically makes twoincisions 10, 12 in the patient's cornea, close to the limbus, to enablesurgical instruments to gain access to the interior segment of the eyeand to implant an intraocular lens after the cataract crystalline lenshas been removed. For example, an intraocular lens inserter 14 can beinserted through the incision 10 and a positioning device 16 can beinserted through the incision 12.

The surgery typically includes creating a full-circle tear in the centerof the capsular bag on the interior side, called a “capsulorhexis,” andremove the torn circle of the capsule. Then, the cataract crystallinelens is removed using a phacoemulsifer, an ultrasonic infusing andaspirating instrument that breaks up the cataract and aspirates thefragments, removing the cataract.

The lingering cortical material that is attached to the inner surface ofthe capsular bag is then aspirated using an infusion/aspiratinginstrument. The intraocular lens 18 is then inserted using the lensinserter 14 and positioned within the capsular bag using the positioningdevice 16 or other devices.

The lens inserter 14 transfers the flat intraocular lens 18 through thesmall clear corneal incision 10 into the capsular opening(capsulorhexis) and to its final position within the capsular bag. Theinserter 14 pushes the flat lens 18 through a cartridge which causes thelens to fold and pass through a tubular portion of the cartridge whichis placed into the small incision 10. As the lens 18 emerges out of thetubular end of the cartridge 14, it slowly unfolds and returns to itsoriginal flat shape.

Recent advances in femtosecond laser instrumentation has automated theprocess of making entry incisions and the capsulorhexis as well aspre-cutting the cataract making the cataract surgical procedure moreprecise, safer, and easier for the surgeon to execute.

The majority of current lens inserters are manually operated re-usableinstruments with primarily one of two means to push the lens: a leadscrew or plunger. The lead screw approach provides consistent and smoothdelivery of the lens, however slowly, and requires the surgeon or anassistant to turn the manual lead screw as the surgeon positions the tipof the instrument

The plunger approach does not require an assistant, as the surgeon usestheir thumb to drive the lens forward, much like injecting a drug from asyringe. Additionally, the surgeon can more readily control the speed ofdelivery, swiftly moving though the less critical portions and slowingfor the more delicate segments. A draw back of the plunger approach canemerge when the lens becomes stuck resulting in a more forceful push bythe surgeon where upon clearance of the hang-up, the lens can over-shootits exit and injure the patient.

Re-usable instrumentation requires re-processing (cleaning andsterilization) resulting in additional instrumentation overhead andincreased risk of Toxic Anterior Segment Syndrome (TASS)http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5625a2.htm.

Recently, efforts have been made to perform such lens replacementsurgeries using smaller corneal incisions. For example, as shownschematically in the illustration of FIG. 3, typically, the distal endof an intraocular lens inserter 14 is inserted completely through theincision 10, during a procedure of inserting an intraocular lens 18.

However, with reference to FIG. 4, recently surgeons have been adoptinga “wound-assist” technique, wherein only a small portion of the tip 20of the intraocular lens inserter 14 is inserted into the incision 10,wherein the incision 10 is smaller than the incisions previously made,such as during the procedure illustrated in FIG. 3. As such, theintraocular lens 18, in its folded state, is pushed through and slidesalong interior surfaces of the incision 10. This allows the incision 10to be smaller and the wound itself (incision 10) becomes a lumen forinserting the lens 18 into the eye.

During such a procedure, the surgeon can use the distal end 20 of thetip of the intraocular inserter 14 to help hold the incision 10 open.For example, the surgeon might apply a lateral force in the direction ofarrow 22 in order to hold the incision 10 open such that the lens 18 canbe pushed therethrough.

SUMMARY OF THE INVENTION

An aspect of at least one of the inventions disclosed herein includesthe realization that an intraocular lens inserter design can allow asurgeon to actuate and thus discharge a lens from an inserter devicewith one hand can provide a surgeon and can also reduce the manual forcethat must be applied by the surgeon. For example, in some knownconventional devices, such as plunger devices, a surgeon must usesignificant manual force against the proximal end of the plunger to pushthe lens through the end of the inserter device. This makes it moredifficult for the surgeon to hold the device in the desired orientationand location during insertion. This problem is more significant in thesurgical procedures more recently adopted such as that described abovewith reference to FIG. 4. Thus, an intraocular lens insertion devicethat provides assisted discharge force can help a surgeon perform thesurgical procedure as desired.

Another aspect of at least one of the inventions disclosed hereinincludes the realization that significant costs for such devices can bereduced by the use of an inserted device having an incorporatedmechanism for storing energy for providing a discharge force, which isnot connected by a tether, for example, to a separate console. Forexample, some known types of surgical devices include electrical motorsor pneumatic systems that are operated by standalone consoles thatprovide either electrical power to an electric motor or compressed airto a compressed air motor inside a handpiece of a surgical device. Suchsystems require the surgeons to purchase or rent the console devices foruse with such specialized surgical tools.

Thus, by providing an intraocular lens inserter with energy storage forproviding a discharge force, the intraocular lens inserter is moreportable and avoids the requirement for a surgeon to purchase or rent aseparate standalone console.

Another aspect of at least one of the inventions disclosed hereinincludes the realization that compressible energy storage devices, suchas springs, or compressed air, can provide convenient and portable meansfor storage of energy which can be output as forces. However, suchenergy storage devices are more difficult to control for providing, forexample, constant velocity output. Thus, an aspect of at least one ofthe inventions disclosed herein includes the realization that providingan actuating circuit operating with a substantially incompressiblefluid, such as a liquid, accommodates the use of mechanisms that canprovide more fine control over the velocity of downstream components,even where energy is supplied by a compressible storage device, such assprings or compressed air.

Another aspect of at least one of the inventions disclosed hereinincludes the realization that a hand-held intraocular lens inserter canbe made with an incorporated energy storage device and a movementcontrol actuator, with sufficient simplicity that the resulting devicecan be designed as a single use device and thus disposable, therebyavoiding the costs of resterilization and the potential forcross-contamination. Thus, for example, an intraocular lens inserterdevice can include a compressible energy storage device and an actuatorconfigured to operate with a substantially incompressible fluid forcontrolling the release of the energy stored by the energy storagedevice and the movement of downstream components, such as a lensinsertion rod.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the Detailed Description and claims when considered inconjunction with the following figures, wherein like reference numeralsrefer to similar elements throughout the figures.

FIG. 1 is an enlarged sectional view of a human eye with an intraocularlens inserter inserted through an incision in the cornea and apositioning device inserted through a second incision, with anintraocular replacement lens shown as being partially ejected from theintraocular lens inserter.

FIG. 2 is a front plan view of the procedure illustrated in FIG. 1.

FIG. 3 is a schematic diagram of a portion of the arrangement shown inFIG. 1, with the distal tip of an intraocular lens inserter insertedcompletely through an incision and discharging a replacement lens.

FIG. 4 is a schematic illustration of a different procedure than thatillustrated in FIG. 3, in which the distal tip of the intraocular lensinserter is inserted only partially into the incision.

FIG. 5 is a schematic illustration of an embodiment of an intraocularlens inserter.

FIG. 6 is a perspective view of a further embodiment of an intraocularlens inserter.

FIG. 7 is a side elevational and cross-sectional view of the intraocularlens inserter of FIG. 6.

FIG. 8 is a side elevational and cross-sectional view of a portion of ahousing member of the intraocular lens inserter of FIG. 7.

FIG. 9 is an enlarged sectional view of an energy storage portion of thelens inserter of FIG. 6 and in a partially exploded view;

FIG. 10 is also a cross-sectional view of lens inserter of FIG. 6showing an energy storage device being pierced by a piercing device andwithin end caps screwed down over the energy storage device.

FIG. 11 is a cross-sectional view of the inserter of FIG. 6 showingmovement of a piston after an expanding gas has been discharged from theenergy storage device.

FIG. 12 is an enlarged sectional view of an actuator portion of theinserter of FIG. 6.

FIG. 13 is an exploded view of a lens cartridge holder portion of theinserter of FIG. 6.

FIG. 14 is an enlarged perspective and exploded view of the insertershown in FIG. 13.

FIG. 15 is an enlarged side elevational view of a lens cartridge removedfrom the lens cartridge holding portion.

FIG. 16 is a view of the inserter of FIG. 15 with the lens cartridgeinserted into the lens cartridge holder portion.

FIG. 17 is a partial cross-sectional view of the inserter of FIG. 16prior to the lens cartridge being engaged with a plunger.

FIG. 18 is a cross-sectional view of the inserter shown after the lensholder portion has been moved axially to engage the plunger with thelens cartridge.

FIG. 19 is an illustration of a further embodiment of the inserter inFIG. 6, in which the energy storage device is in the form of a spring.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the proceeding technical field, background,brief summary, or the following detailed description.

Certain terminology may be used in the following description for thepurpose of reference only, and thus are not intended to be limiting. Forexample, terms such as “upper”, “lower”, “above”, and “below” refer todirections in the drawings to which reference is made. Terms such as“proximal”, “distal”, “front”, “back”, “rear”, and “side” describe theorientation and/or location of portions of the component within aconsistent but arbitrary frame of reference which is made clear byreference to the text and the associated drawings describing thecomponent under discussion. Such terminology may include the wordsspecifically mentioned above, derivatives thereof, and words of similarimport. Similarly, the terms “first”, “second”, and other such numericalterms referring to structures do not imply a sequence or order unlessclearly indicated by the context.

The inventions disclosed herein are described in the context ofintraocular lens inserters for the treatment of cataracts. However, theinventions disclosed herein can be used in other context as well withregard to surgical devices that are required to discharge devices, forexample, into or beyond the tissues of an animal, such as a human.

With reference to FIG. 5, an intraocular lens inserter 100 can includean energy storage device 102, an actuator device 104, and a lensdischarge portion 106. The energy storage portion 102 can be in the formof any type of energy storage device. In some embodiments, the energystorage portion 102 is in the form of a device for storing acompressible fluid, mechanical springs, or other compressible types ofenergy storage devices. Other types of energy storage devices can alsobe used.

In some embodiments, the energy storage portion 102 can be configured todischarge mechanical energy from the energy stored therein. For example,where the energy storage device 102 is in the form of a compressed gascontainer, the energy storage device 102 can discharge such compressedgas which therefore provides an output of mechanical energy. Similarly,where the storage device 102 is in the form of a mechanical spring, sucha spring can output linear or torsional movement, which is also a formof mechanical energy.

The actuator portion 104 can be any type of actuator configured toprovide controllable actuation of the output of mechanical energy fromthe energy storage portion 102. For example, in some embodiments, theactuator portion 104 can be in the form of a mechanical or electronicbutton or lever for providing a user with means for controlling theoutput of mechanical energy from the energy storage portion 102. Forexample, the actuator 104 can be in the form of a button or otherelectronic devices configured to provide variable resistance or movementassociated with a mechanical member used for outputting the energy fromthe energy storage portion 102. The actuator portion 104 can alsoprovide for the control of an output member configured for interactionwith the intraocular lens portion 106. For example, the actuator portion104 can include an output plunger or other device for interacting withthe intraocular lens portion.

The intraocular lens portion 106 can be configured to interact with orretain an intraocular lens cartridge which is widely commerciallyavailable from several different sources. For example, the intraocularlens portion 106 can be configured to releasably engage with anintraocular lens cartridge commercially available as a Monarch availablefrom Alcon. The intraocular lens portion 106 can also be configured tomove between an open position configured for allowing an intraocularlens cartridge to be engaged with the lens portion 106 and a closedportion in which the lens portion 106 engages with the lens cartridge.

As such, in operation, the actuator portion 104 can be manipulated by auser, such as a surgeon, to control the output of mechanical energy fromthe energy storage portion 102, to thereby control the discharge of alens from a lens cartridge retained by the lens portion 106. Further,the inserter 100 can be configured to be hand-held, and in someembodiments, disposable.

With reference to FIGS. 6-18, a further embodiment of the lens inserter100 is illustrated there and identified by the reference number 100A.The features and components of the lens inserter 100A that can be thesame or similar to corresponding components of the lens inserter 100have been identified with the same reference numeral, except that theletter “A” has been added thereto.

With reference to FIGS. 6-8, the intraocular lens inserter 100A alsoincludes an energy storage portion 102A, an actuator portion 104A, and alens portion 106A.

In the illustrated embodiment, with reference to FIG. 8, the inserter100A includes a main body portion 200 which includes various cavities,recesses, and conduits, and, in the present embodiment, provides forcommunication between the energy storage portion 102A and the actuatorportion 104A. FIG. 8 illustrates the body portion 200 with all othercomponents removed therefrom. In some embodiments, optionally, the bodyportion 200 can be made from a single piece of material forming amonolithic body. However, other configurations can also be used.

In some embodiments, the body portion 200 includes an energy storagereceiving portion 202. In some embodiments, the receiving portion 202 isconfigured as a recess within the body 200, sized and configured toreceive a container of compressed gas. In some embodiments, the recess202 can be sized to receive a canister of compressed carbon dioxide 204.Such containers of compressed gas and, in particular, carbon dioxide,are widely commercially available.

The housing 200 can also include a piston chamber 206 configured toreceive gas discharged from the container 204. The piston chamber 206can include devices for interacting with the gas from the container 204for providing usable mechanical energy. For example, as shown in FIG. 7,a piston 208 can be disposed in the piston chamber portion 206. In someembodiments, the piston 208 subdivides the piston chamber portion 206into a gas-receiving portion and a liquid-receiving portion 210.

The housing 200 can also include a conduit 212 connecting the energystorage portion 102A with the actuator portion 104A. For example, theconduit 212 can provide a flow path between the liquid receiving portion210, along the direction of arrow 216, into the actuator portion 104A.

The conduit 212 can include an aperture in a portion of theliquid-receiving portion 210, that leads into an actuator controlportion 214, then to a lateral connector portion 218, into a furtherliquid-receiving portion 220 of the actuator portion 104A.

The actuator receiving portion 214 can be configured to receive anactuator for controlling the flow of fluid along the conduit 212.Additionally, the chamber 220 can be configured to receive a piston 222,described in greater detail below.

With continued reference to FIG. 8, the body 200 can also include anactuator mounting portion 230. The actuator mounting portion 230 can bein the form of a projection 232 extending radially outwardly from thelongitudinal axis L of the body 200. The projection 232 can include anaperture 234 and could be configured to receive an actuator rod 236(FIG. 7).

The body 200 can also include various other outer surfaces and devicesfor engagement with a sliding cartridge engagement member 240 (FIG. 6),described in greater detail below. For example, the outer surface 242 ofthe actuator portion 104A of the body 200 can include various engagementdevices 246, 248, and/or other ridges for providing alignment andengagement with the engagement device 240. Such features are describedin greater detail below with reference to FIG. 14.

With reference to FIGS. 9-11, the storage portion 102A is illustrated infurther detail, including various components that can be included withinthe body member 200. The distal end 250 of the body member 200 caninclude internal threads 252 configured for engagement with externalthreads 254 disposed on a removable end cap 256.

Additionally, the energy storage portion 102A can include a bulkheadmember 260. The bulkhead member 260 can be configured to provide forsecure engagement with a chosen energy storage device used with theenergy storage portion 102 a. As noted above, the illustrated embodimentis designed for use with a cartridge of compressed carbon dioxide 204.Thus, in the illustrated embodiment, the bulkhead member 260 includes anupstream end 262 configured for abutting engagement with a distal end205 of the cartridge 204. The bulkhead member 260 can also include asealing device, such as an O-ring 264, for providing a sealingengagement with an inner surface of the piston chamber 206. In theillustrated embodiment, the bulkhead member 260 remains stationaryduring operation. Thus, the inserter 100 a also includes a set screw 266which extends through the body portion 200 for secure engagement withthe bulkhead member 260. Other designs can also be used.

The energy storage portion 102A can also include an accumulator piston280. In the illustrated embodiment, the accumulator piston 280 isslidably engaged with two surfaces. Firstly, the accumulator piston 280includes a first portion 282 engaged with an inner surface of thebulkhead member 260 and a downstream portion 284 engaged with an innersurface of the piston chamber 206. Additionally, in the illustratedembodiment, the piston 280 includes a piercing needle 286 which isconfigured to pierce a seal that is commonly used on compressed gascartridges, such as the carbon dioxide compressed gas cartridge 204.

The piston 280 is configured to move slidably along the longitudinalaxis L of the inserter 100A. As such, the piston 280 includes an O-ring288 for sealing against the inner surface of the bulkhead 260 and asecond O-ring 290 for providing a sliding seal with the inner surface ofthe piston chamber 206.

In some embodiments, the O-ring seal 288 can be configured to maintainall of the gas discharged from the cartridge 204 in the area 292disposed between the piston 280 and the cartridge 204. Additionally, thepiston chamber 206 can be configured to receive a substantiallyincompressible fluid, such as a liquid, including but not limited to,silicone oil, propylene glycol, glycerin, saline, water, or othersubstantially incompressible fluids. For purposes of illustration, thepiston 280 and the downstream or distal portion of the piston chamber206 can be considered as a substantially incompressible fluid-receivingchamber 300. Thus, in some embodiments, the O-ring 290 is configured tomaintain any liquid or fluid in the chamber 300 in the distal portion ofthe chamber 206.

During operation, when the cap 256 is screwed into the threads 252, thecartridge 204 is thereby pushed into the piercing needle 286, therebyopening the cartridge 204 and releasing the compressed gas therein intothe space between the cartridge 204 and the bulkhead 260 and the distalproximal end portion 282 of the piston 280.

With reference to FIG. 11, when the actuator portion 104A is operatedappropriately, the pressurized gas from the cartridge 204 continues toexpand into the gas-receiving portion 292, thereby pressurizing anyfluid or liquid in the substantially incompressible fluid receivingportion 301. Actuation of the actuator portion 104A allows thepressurized fluid in the chamber 301 to flow outwardly therefrom andinto the chamber 220 to thereby drive the piston 222 longitudinally inthe direction of arrow R (FIG. 11), described in greater detail below.

With continued reference to FIG. 12, the actuator portion 104A caninclude an actuator member 300 mounted relative to the housing member200 so as to be movable between an unactuated position (illustrated inFIG. 12) and an actuated position (not shown). For example, the levermember 300 can be attached to the housing 200 with the hinge member (notshown), such that the actuator member can be pivotable along the arc302. The actuator member 300 can also be engaged with the rod 236 whichcan be configured to provide a flow control function for controlling theflow of substantially noncompressible fluid from the chamber 300 towardthe chamber 220 for moving the piston 222. For example, the piston rod236 can include a distal end 240 which extends through the aperture 234of the projection 232 and a proximal end 320 configured to provide aflow control function.

The distal end 240 of the rod 236 can include a slot for engagement witha screwdriver to provide adjustment of the positioning of the rod 236.For example, the lever member 300 can also include an engagement member310 pivotally mounted to the lever member 300. The engagement member 310can include a threaded portion 312 configured for engagement withexternal threads on the distal portion 240 of the rod 236.

Additionally, a spring 314 can provide a bias of the lever member 300 tothe unactuated position. Connected as such, when the lever mover 300 ismoved through the arc 302, and more particularly, when the lever member300 is moved downwardly from the position illustrated in FIG. 12, theengagement member pulls the rod 236 in a distal direction D, therebymoving the flow control portion 320 in the direction of arrow D. Thespring 314 provides a bias return action for returning the lever member300 to the position illustrated in FIG. 12, when released by a user.

With continued reference to FIG. 12, the proximal portion 320 of the rod236 can include a piston member 322 and seal, in the form of an O-ring324. The proximal portion 320 can also include a needle portion 326configured to cooperate with a throat portion 328. Using well knowntechniques, the engagement and cooperation of the needle portion 326with the throat portion 328 can be used to control a flow ofsubstantially incompressible fluid along the conduit 212. For example,when the lever 300 is moved downwardly from the position illustrated inFIG. 12, the piston rod is moved distally in the direction D, therebymoving the needle portion 326 also in the direction of arrow D, therebyforming or increasing a gap between the needle portion 326 and thethroat portion 328. As such, fluid flows through the conduit 212, forexample, a substantially incompressible fluid pressurized by the piston208 due to interaction with gas discharged from the cartridge 204 canthereby flow through the conduit 212 toward the piston 222.

When the substantially incompressible fluid presses against the piston222, the piston 222 also moves in the direction of arrow D. Thismovement of the piston 222 can be used to discharge a lens from thecartridge 400. More specifically, as illustrated in FIGS. 12 and 13, aplunger 402 can be attached to a distal end of the piston 222. Thus, asthe piston 222 is moved by the flow of fluid through the conduit 212,the plunger 402 is also moved in the direction of arrow D. This movementof the plunger 402 can be used to discharge a lens disposed within thecartridge 400, in a technique that is well known in the art.

With reference to FIGS. 13 and 14, the cartridge engagement member 240can include a cartridge receiving portion 430. For example, thecartridge receiving portion 430 can include a distal wing engagementportion 432 and a body receiving portion 434. The wing receiving portion432 and the body receiving portion 434 can be sized in accordance withthe outer dimensions of commercially available lens cartridges 400,which are well known in the art.

The distal wing receiving portion 432 can include a recess designed toengage the wings 436 of the lens cartridge 400. Thus, when the cartridge400 is engaged with the cartridge receiving portion 430, as shown inFIG. 6, the cartridge 400 is generally aligned with the plunger 402.

With continued reference to FIGS. 15 and 16, the cartridge receivingportion 430 can optionally include a proximal engaging portion 440configured to engage with a proximal portion of the cartridge 400. Forexample, in some commercial embodiments of the cartridge 400, thecartridge 400 includes rearward wings 442 or other rearward surfaces.The cartridge engagement portion 430, therefore, can include anadditional proximal recess 444 and an engagement device 446, for apositive engagement with the wings 442. Thus, as shown in FIG. 16, whenthe cartridge 400 is engaged both with the forward engagement portion432 and the rearward engagement portion 444, with the projection 446extending over the rearward wings 442, the cartridge 400 is moresecurely seated within the cartridge receiving portion 430.

This can provide a substantial benefit to a surgeon using the inserter100 a. For example, with the projection 446 extending over the rearwardwing 442, if the surgeon applies a force to the inserter 100 a, in thedirection of arrow F (FIG. 16), a torque T can be created or impartedonto the cartridge 400, thereby tending to cause the cartridge to pivotabout the distal receiving portion 432, which can thereby tend to causethe proximal end of the cartridge 400 to lift upwardly in the directionof arrow U. However, the engagement portion 446 can help retain theproximal portion of the cartridge 400 within the receiving portion 430.This type of force can be created during execution of surgicalprocedures that are becoming more common, such as that described abovewith reference to FIG. 4, known as the “wound-assist” technique.

With continued reference to FIGS. 14-18, the member 240 can also beslidably engaged with the body 200. Thus, the member 240 can includevarious internal surfaces configured to cooperate with outer surfaces ofthe body 200. Thus, the member 240 can be slid longitudinally along thebody 200, parallel to the longitudinal axis L of the inserter 100 a.

For example, with reference to FIGS. 17 and 18, the portion 240 can bemoved to a distal position, show in FIG. 17. In this position, the lensreceiving portion 430 is spaced apart from the plunger 402. As such, thecartridge 400 can be inserted into the cartridge receiving portion 430without interference of the plunger 402. Thus, after the cartridge isreceived as such, as shown in FIG. 18, the portion 240 can be slidbackwards relative to the body 200 until the plunger 402 engages orpresses against a lens within the cartridge 400.

As noted above, the body 200 can include various detents or ramps orother portions 246, 248 which can engage with a portion of the member240 for providing positive engagement into various positions. Forexample, the portion 240 can include a ramp and hook portion 460configured to engage with the portion 246 and portion 248 of the housingmember 200. Thus, the member 240 can be positively engaged in theposition illustrated in FIG. 17 with the body member 200, and then whenpulled in the proximal direction, so as to move the plunger 402 into thecartridge 400, the portion 460 can engage with the proximal portion ofthe housing 200 to thereby engage into a retracted position. Otherdesigns can also be used to provide for the convenient insertion andremoval of the cartridge 400.

With reference to FIG. 19, a further embodiment of the inserter 100 a isillustrated therein and identified generally by the reference numeral100 b. The components of the inserter 100 b that can be the same orsimilar to the inserter 100 a are identified with the same referencenumerals, except that a letter “b” has been added thereto.

With continued reference to FIG. 19, the energy storage portion 102 bcan be configured to use a compressive energy storage function of acoiled spring 500. The coiled spring can include a distal end 502engaged with a piston 504 and a proximal end 506 held in place with aremovable cap 256 b. The piston 504 can be configured to form a seal,for example, with an O-ring 506, so as to operatively contain asubstantially incompressible fluid in the chamber 202 b. The remainingportions of the inserter 100 b can be constructed in accordance with thedescription of the inserter 100 a above.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. Rather, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application.

What is claimed is:
 1. An intraocular lens inserter comprising: anactuator portion comprising an actuator member and a plunger, theactuator portion configured to allow a user to control discharge ofenergy from an energy storage device to the plunger by using theactuator member; and an intraocular lens portion configured to receivean intraocular lens for insertion into an eye of an animal.
 2. Theintraocular lens inserter of claim 1, wherein the energy storage devicecomprises a compressible energy storage medium.
 3. The intraocular lensinserter of claim 2, wherein the compressible energy storage mediumcomprises a pressurized gas.
 4. The intraocular lens inserter of claim2, wherein the compressible energy storage medium comprises a two-phasepressurized gas.
 5. The intraocular lens inserter of claim 2, whereinthe compressible energy storage medium comprises a spring.
 6. Theintraocular lens inserter of claim 1, wherein the intraocular lensinserter further comprises an energy storage portion, the energy storageportion comprising a receiving portion configured to receive an energystorage device.
 7. The intraocular lens inserter of claim 6, wherein thereceiving portion is sized to receive a compressed gas container suchthat the compressed gas container can be contained in the intraoculargas inserter.
 8. The intraocular lens inserter of claim 7, wherein theintraocular lens inserter further comprises a piercing member, thepiercing member configured to pierce a seal on the compressed gascontainer.
 9. The intraocular lens inserter of claim 1, wherein theactuator portion further comprises an incompressible fluid between theenergy storage device and the plunger, the incompressible fluidconfigured to transfer energy from the energy storage device to theplunger.
 10. The intraocular lens inserter of claim 9, wherein theactuator portion further comprises a control portion with an actuatoroperably coupled to the actuator member, the control portion configuredto control the flow of the incompressible fluid from the energy storageportion to the plunger.
 11. The intraocular lens inserter of claim 10,wherein the actuator comprises an actuator rod, the actuator rodoperably coupled to the actuator member at a first end and having anactuator piston at a second end, the actuator rod slidably translatablewithin the control portion.
 12. The intraocular lens inserter of claim9, wherein the intraocular lens inserter further comprises anaccumulator piston contained in an accumulator piston chamber, theaccumulator piston sealingly dividing the accumulator piston chamberinto a first subchamber and second subchamber, the first subchamber incommunication with the energy storage device and the second subchamberin communication with the incompressible fluid.
 13. The intraocular lensinserter of claim 12, wherein the intraocular lens inserter furthercomprises a plunger piston in a plunger piston chamber, the plungerpiston sealingly in communication with the incompressible fluid at afirst end and connected to the plunger at a second end.
 14. Theintraocular lens inserter of claim 1, wherein the intraocular lensportion is configured to receive an intraocular lens cartridge having anouter housing and an intraocular lens disposed therein.
 15. Theintraocular lens inserter of claim 14, wherein the intraocular lensportion comprises a first distal end configured to engage a distalportion of the intraocular lens cartridge and a proximal end configuredto engage a proximal portion of the intraocular lens cartridge.
 16. Theintraocular lens inserter of claim 14, wherein the intraocular lensportion further comprises a sliding cartridge engagement member, thesliding cartridge engagement member configured to be slidably movablewith respect to the actuator portion.
 17. The intraocular lens inserterof claim 16, wherein the sliding cartridge engagement member isconfigured to attach to a main body portion of the intraocular lensinserter and wherein the plunger is configured to extend into anintraocular lens cartridge, the plunger being slidably movable withrespect to the intraocular lens cartridge.
 18. An intraocular lensinserter comprising: an intraocular lens portion comprising anintraocular lens; an actuator portion comprising a plunger and asubstantially incompressible fluid, the actuator portion communicatingwith an energy storage device and configured to apply energy from theenergy storage device to the plunger via the incompressible fluid fordischarging the intraocular lens.
 19. The intraocular inserter of claim18, wherein the energy storage device comprises a pressurized gas. 20.The intraocular lens inserter of claim 18, wherein the energy storagedevice comprises a two-phase pressurized gas.
 21. The intraocularinserter of claim 18, wherein the incompressible fluid is a liquid. 22.The intraocular inserter of claim 21, wherein the actuator portioncomprises at least one actuator configured to control a flow of theincompressible fluid.
 23. The intraocular lens inserter of claim 18,wherein the intraocular lens inserter further comprises an energystorage portion, the energy storage portion comprising a pistonconfigured to transfer energy from the energy storage device to thesubstantially incompressible fluid
 24. A method for discharging anintraocular lens from an intraocular lens cartridge, the methodcomprising: releasing stored energy from an energy storage device;transmitting the released energy from the energy storage device to aplunger; and translating the plunger with the transmitted energy. 25.The method of claim 24, wherein the energy storage device comprises acompressible energy storage medium.
 26. The method of claim 25, whereinthe compressible energy storage medium comprises a compressed gas. 27.The method of claim 24, wherein the step of transmitting the releasedenergy from the energy storage device to a plunger comprisestransmitting the released energy via an incompressible fluid.
 28. Themethod of claim 27, additionally comprising controlling the flow ofincompressible fluid to the plunger.
 29. The method of claim 24,additionally comprising inserting an intraocular lens cartridge into theintraocular lens inserter and translating an intraocular lens cartridgevia translation of the plunger.
 30. An intraocular lens insertercomprising: an intraocular lens portion configured to receive anintraocular lens for insertion into an eye of an animal; a plungerconfigured to contact the intraocular lens and discharge the intraocularlens from the intraocular lens portion; and a means for controlling thetransmission of energy from an energy storage device to the plunger.